New Abbott Vitamin D Test Available for Use in the European UnionBy Abbott, PRNE
Monday, January 24, 2011
ABBOTT PARK, Illinois, January 25, 2011 - Abbott (NYSE: ABT) has announced CE marking (Conformite Europeenne) for
the ARCHITECT 25-OH Vitamin D assay, a new diagnostic test to measure levels
of vitamin D in blood using Abbott's ARCHITECT automated instrument system.
According to the International Osteoporosis Foundation, vitamin D
deficiency is a global health issue. The percentage of the European
population that is vitamin D insufficient is high, with some countries
exceeding 75 percent. Global demand for patient testing is estimated to be
growing at 50 percent per year due to increasing medical knowledge of the
adverse health implications associated with vitamin D deficiency.
The ARCHITECT 25-OH Vitamin D assay is a fully-automated immunoassay that
can help laboratories manage the expected increase in vitamin D testing
volumes. It is intended for the quantitative determination of 25-hydroxy
vitamin D in human serum and plasma to aid in the assessment of vitamin D
sufficiency. The 25-hydroxy vitamin D test provides an accurate gauge of
vitamin D status, and its measurement in patients provides opportunities for
preventive and therapeutic interventions.
"As a major diagnostic lab, serum 25-OH vitamin D has become an
increasingly important diagnostic marker to us," said Dr. Frans AL van der
Horst, Reinier de Graaf Group, Diagnostic Center SSDZ, Delft, The
Netherlands. "There has been a great need for a reliable and cost effective
assay. With the introduction of the Abbott test, we can fulfill these needs
and significantly improve the efficiency of the workflow in our routine lab."
Low concentrations of vitamin D can cause secondary hyperparathyroidism
(high levels of parathyroid hormone or PTH) and diseases related to impaired
bone metabolism. When PTH is abnormally high, a person loses calcium from
his/her bones and has an elevated risk for bone density loss.
Consequently, low vitamin D levels can cause skeletal disorders, such as
rickets in children and osteopenia in adults, and have been linked to an
increased risk of hip fracture and falls. Studies have also shown that
vitamin D deficiency may increase risk for some cancers, cardiovascular
problems, autoimmune disorders and infectious diseases.
"Vitamin D deficiency is recognized as a global health problem, and
vitamin D supplementation should be considered for all people at risk of
vitamin D deficiency," said Jean-Claude Souberbielle, Ph.D., Hopital
Necker-Enfants Malades, Universite Paris. He added that determination of the
serum vitamin D concentration and supplementation according to the measured
level is important for patients with osteoporosis, chronic kidney disease,
abnormalities in absorbing food nutrients, and more generally, in those with
a disease or a treatment that may impair bone health.
"The new vitamin D assay is a valuable and convenient addition for Abbott
ARCHITECT customers, who now have an automated test to use on samples that
previously might have been sent to outside reference labs," said Brian
Blaser, senior vice president, diagnostic operations, Abbott. "This will save
labs time and money as they work to manage increases in the volume of vitamin
D tests they perform."
The ARCHITECT 25-OH Vitamin D assay is not approved for use in the United
About Abbott ARCHITECT
The ARCHITECT family of analyzers delivers the first truly integrated
portfolio of immunoassay and clinical chemistry instruments. Since the
introduction of the ARCHITECT i2000 a decade ago, Abbott has developed and
launched a series of ARCHITECT analyzers that are delivering unprecedented
flexibility, automation and convenience to today's clinical laboratory. With
its extensive menu of more than 170 assays, ARCHITECT enables laboratories
facing increasing cost pressures to reduce labor, optimize throughput and
enhance overall productivity, while standardizing data management processes
and optimizing inventory control. The ARCHITECT family provides features that
minimize training and reduce inventory costs and sample contamination
potential, which results in improved performance and outcomes for
laboratories, physicians and patients.
About Abbott Diagnostics
Abbott is a global leader in in vitro diagnostics and offers a broad
range of innovative instrument systems and tests for hospitals, reference
labs, molecular labs, blood banks, physician offices and clinics. With more
than 69,000 customers in more than 100 countries, Abbott's diagnostic
products offer customers automation, convenience, bedside testing,
cost-effectiveness and flexibility. Abbott has helped transform the practice
of medical diagnosis from an art to a science through the company's
commitment to improving patient care and lowering costs.
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
Media, Darcy Ross, +1-847-937-3655, or investors, Angela Duff, +1-847-938-6894, both of Abbott
Tags: Abbott, Abbott park, Europe, Illinois, January 25